Unlock the power of video assessments in your clinical operations with our comprehensive white paper, “From Clinical Visits to Remote Assessments: The Impact of Video Electronic Outcome Assessments (vCOAs).”

This guide explores the use of video Clinical Outcome Assessments (vCOAs), a transformative subset of eCOAs, offering clinical operations teams the tools to capture real-world data more effectively.

In this white paper, you will learn

1. How vCOAs leverage patients’ own devices to perform tasks and assessments, enhancing data accuracy and reducing biases with automated data analyses.
2. The benefits of remote video assessments, making trials more inclusive and reducing the need for patients to travel, minimising stress and increasing participation.
3. The capabilities of real-time tracking and AI-driven analytics in providing immediate, actionable insights, improving the quality and effectiveness of clinical studies.

Three Reasons to Download this White Paper

1. Innovative Trial Design: Gain insights into how vCOAs can invigorate clinical trial designs by enabling remote video assessments and incorporating real-time data analysis.

2. Operational Efficiency: Discover how the automation of vCOAs reduces the burden on clinical staff, streamlines quality control, and ensures high standards of data privacy and security.

3. Improved Patient Outcomes: Learn how continuous and precise monitoring through vCOAs can enhance patient safety, improve treatment outcomes, and provide a more comprehensive understanding of patient health during trials.

Download our white paper and empower your clinical operations team with the knowledge to implement effective, scalable, and patient-centric video eCOAs.

Access the paper

How to Meet Regulatory & Compliance Requirements for Capturing eCOAs in Clinical Trials provides in-depth insights into adapting to the evolving landscape of clinical trials technology.

We highlight the integration of Electronic Data Capture (EDC) platforms, Machine Learning, and AI in clinical management to ensure audit readiness and compliance with the latest FDA and EMA guidelines. Explore the transition from traditional Computer System Validation (CSV) to a more dynamic Computer System Assurance (CSA), focusing on risk-based approaches and minimizing extensive documentation.

In this white paper you will learn:

1. Transitioning from CSV to CSA. Understand the shift from traditional CSV to the more dynamic CSA. Learn about the FDA’s latest guidelines which emphasize risk-based approaches, reduce the burden of documentation, and ensure the security, availability, and reliability of clinical trial systems.
2. Adapting to New Regulatory Requirements. Discover how recent regulatory changes impact the management and execution of clinical trials, specifically the integration of Machine Learning and Artificial Intelligence in clinical trial management, and how these technologies meet FDA and EMA standards for data integrity and reliability.
3. Implementing a Robust eQMS with AMP™. Explore how the Aparito Management Platform (AMP™) streamlines your operations, integrates risk management and ensures data integrity across every aspect of your study, keeping you audit-ready and compliant in a complex regulatory environment.

Download the white paper today to ensure your team is equipped with the knowledge to implement effective and compliant eCOA strategies in your clinical trials. Transform your processes, meet regulatory demands, and stay ahead in the fast-evolving world of clinical research.

Access the paper

In the evolving landscape of healthcare and clinical research, the traditional methodologies of assessing patient outcomes are undergoing a significant transformation thanks to the advent of electronic Clinical Outcome Assessments (eCOAs), marking a pivotal shift from conventional paper-based methods, offering myriad benefits that enhance the accuracy, efficiency, and inclusivity of clinical trials.

eCOAs promise enhanced data quality through direct source capture, real-time access for faster decision-making, and improved patient engagement through user-friendly interfaces. These advancements are not just about improving methods; they reflect a deeper commitment to patient-centred research and a push towards more rigorous, evidence-based practices in drug development.

In this white paper you will learn:

1. How eCOAs boost data collection by enhancing data quality, patient participation, and efficiency in clinical research.
2. The role of eCOAs in enabling diverse participants to join clinical research, breaking down barriers for those with limited access to traditional study sites.
3. An overview of the expanded categories of COAs, including the latest FDA-guided developments, and how digital technologies are reshaping the way health outcomes are measured and analyzed

With examples like the SARAhome for ataxia and DMDhome for Duchenne Muscular Dystrophy, the paper illustrates the potential of eCOAs to capture nuanced changes in patient conditions and treatment impacts, offering a richer, more detailed view of patient experiences.

Moreover, the development of novel eCOAs and the digitisation of existing ones underscore the flexibility and adaptability of electronic assessments to meet the evolving needs of clinical research.

Download the full white paper to explore the transformative potential of eCOAs and discover how they are reshaping clinical trials.

Access the paper

Wearable devices (wearables) are a rich source of health-related data that can help accelerate study timelines, reduce participant burden, generate novel insights, and make faster, better-informed clinical decisions based on high-quality, real-world evidence.

The use of wearables in real-world studies has seen significant growth, with analysts predicting that 70% of clinical trials will incorporate wearable devices by 2025. Clinicaltrials.gov reports approximately 1,500 trials currently using wearables, with over 700 completed as of August 2023.

Commercial-grade wearables have the potential to transform clinical trials, enabling efficient and cost-effective remote monitoring. They have been successfully used to monitor wearing-off symptoms in Parkinson’s Disease patients and have shown excellent accuracy compared to gold standards in cardiovascular disease assessment.

But how do you select a wearable, which measurements should you choose, and how do you go about operationalising a study using wearables?

Aparito has gained valuable experience implementing consumer wearables in global studies and understanding both the opportunities and challenges they present.

In this white paper, we share:

1. our work utilising commercial-grade wearables in global studies with 3000 patients enrolled across two dozen countries spanning EMEA, AMER and APAC
2. the myriad choices one must navigate to select the right wearable device considering factors such as data accuracy, device compatibility, and participant acceptance
3. what’s next for wearable devices in clinical trials of the future?

Access the paper

Paper-based patient-reported outcomes (pPROs) remain a popular means of data collection in clinical trials due to their lower setup costs when compared to electronic PROs (ePROs), although the cost-saving benefits of ePROs rapidly eclipse the initial savings made through pPROs. Furthermore, compliance rates for ePROs range from 90% to 97%, compared to the 30% or lower compliance rate seen for pPROs.

The US Food and Drug Administration (FDA) has made it clear that electronic capture of clinical trial source data over paper-based data collection is the preferred option.

It has been almost a decade since the FDA made their preferences known, so why do sponsors and contract research organisations (CROs) continue to choose pPROs, when the evidence suggests that ePROs are cheaper and more effective in the long term?

In this white paper, we explore why pPROs prevail despite their shortcomings and why ePROs will continue their increasing adoption as their benefits become clearer.

Access the paper

We are pleased to announce the completion of recruitment for our study to validate the video Timed Up-and-Go (vTUG) as a means of monitoring Parkinson’s disease (PD) patients’ gait and balance at home.

Close monitoring of the disease in each patient is an approach that enabled us to develop the vTUG, an eCOA where weekly assessments provide a more meaningful measure of gait and balance than a conventional snapshot visit conducted once a year.

This study aims to validate the usability and feasibility of digital outcome assessments and the development of remote endpoints to follow up with patients living with PD, including progression of the disease, treatment effects and balance and, possibly testing the effect of new drugs within drug trial boundaries.

In this white paper, we explore the deployment of vTUG into the real world and how it enables follow-up of patients living with PD in their everyday lives.

Access the paper